| CTRI Number |
CTRI/2013/09/003965 [Registered on: 10/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
23/08/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
DESCRIPTIVE PROSPECTIVE STUDY |
| Study Design |
Other |
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Public Title of Study
|
ROLE OF BLOOD LEVELS OF URIC ACID,C-REACTIVE PROTEIN AND TROPONIN-T IN HEART DISEASE. |
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Scientific Title of Study
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Role of Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHIREMATH SOURAB |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Dr.HIREMATH SOURAB, DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE Dr.HIREMATH SOURAB,PLOT NO:999
VANTAMURI COLONY, MM EXTENSION, BELGAUM-590016 Belgaum KARNATAKA 575002 India |
| Phone |
7829726532 |
| Fax |
|
| Email |
drsourabmd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Col R Arunachalam |
| Designation |
professor in medicine |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9481846382 |
| Fax |
|
| Email |
arunachalam14759@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrHIREMATH SOURAB |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
Dr.HIREMATH SOURAB, DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE Dr.HIREMATH SOURAB,PLOT NO:999
VANTAMURI COLONY, MM EXTENSION, BELGAUM-590016 Belgaum KARNATAKA 575002 India |
| Phone |
7829726532 |
| Fax |
|
| Email |
drsourabmd@gmail.com |
|
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Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
|
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Primary Sponsor
|
| Name |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY,MANGALORE |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrHIREMATH SOURAB |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF MEDICINE,FATHER MULLER MEDICAL COLLEGE AND HOSPITAL, KANKANADY, MANGALORE Dakshina Kannada KARNATAKA |
7829726532
drsourabmd@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
40 PATIENTS WITH ACUTE CORONARY SYNDROME, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Age greater than or equal to 18 years.
(2)Patients with first episode of Acute Coronary Syndrome.
|
|
| ExclusionCriteria |
| Details |
1)Patients with chronic kidney disease.
(2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level.
(3)Patients in sepsis.
(4) Patients suffering from connective tissue disorders.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| EXPECTED CHANGES IN SERUM PARAMETERS. |
EXPECTED CHANGES IN SERUM PARAMETERS. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome. |
Serum Uric Acid ,C-reactive Protein and troponin T as Prognostic Indicators in patients of Acute Coronary Syndrome. |
|
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Target Sample Size
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Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
02/11/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
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NOT YET |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
| Brief resume of the work 6.1 Need for the study Cardiovascular disease is responsible for 30% of all deaths in the world. About 80% of the global burden of CVD deaths occur in low and middle income countries. India carries a significant portion of this CVD burden .India suffers one of the highest CVD case fatality rates in the world according to an international registry (OASIS) comparing the outcome among patients of Acute Coronary Syndrome.(1) Until now various bio-markers have been studied in patients of Acute coronary syndrome. However, no single marker gives definite prognostic information during the course of the disease. Little information is available about the role of different individual bio markers .Hence a comparative study is attempted using 3 easily measured ,broadly available bio-markers namely serum Uric Acid, troponin-T and C reactive protein targeting different risk indicators like purine metabolism, cardiac myocyte injury and inflammation. Acute coronary Syndrome encompasses MI(STEMI and NSTEMI) and Unstable Angina . Diagnostic criteria (2) (3) 1. Chest discomfort (with or without radiation to the arms, back , neck jaw or epigastrium) or anginal equivalents such as shortness of breath, diaphoresis or extreme fatigue. 2. 12 lead ECG with ST segment elevation in STEMI and ST segment depression or prominent T wave inversion or absence of ST segment Elevation with positive biomarkers of necrosis(troponin T) for NSTEMI 3. Elevated cardiac bio markers like troponin-T. 6.2 Review of Literature 1. Peter A. Kasak and group measured CRP in 446 emergency department patients with acute coronary syndromes. All-cause mortality and hospital discharges for acute myocardial infarction and congestive heart failure were obtained for period of eight years following the event. Kaplan-Meier analyses indicated that the patients with CRP concentrations above the American Heart Association scientific statement cut off 10 mg/ml had a higher rate of death and CHF admissions .Study concluded that patients presenting early with chest pain with elevated CRP concentrations have a greater long term risk for death and heart failure.(4) 2. MY Nadkar and V I Jain studied 100 patients with acute myocardial infarction and 50 controls. Serum uric acid level was measured on day 0,3 and 7 of MI. On all the days serum uric acid levels were higher in patients who were in higher Killip class. Study concluded that serum uric acid levels are higher in patients of acute myocardial infarction correlated with Killip classification.(5) 3. S.M.N.A Nadeem K and group studied 255 consecutive patients admitted with diagnosis of unstable angina and non STEMI . All patients had a baseline troponin T estimation done and repeated twelve hours later in case of an initial negative result. . Study concluded that positive troponin T in patients with UA/NSTEMI is a strong , independent risk predictor of future death and MI.(6) 6.3 Objective of the study: To assess the role of Serum uric acid , C-reactive protein and troponin T as best prognostic indicator in patients of Acute Coronary syndrome admitted in Father Muller Medical College Hospital. | | Materials and Methods 7.1 Source of data: The data will be collected from patients admitted in Father Muller’s Medical College Hospital with acute coronary syndrome from 1st August 2011 to 1st August 2012. 7.2. Method of collection of data: STUDY DESIGN The study will be a descriptive prospective study of the patients admitted in Father Muller’s Medical College with Acute coronary syndrome The study will include a minimum of 40 patients diagnosed with acute coronary syndrome .Three bio markers namely troponin-T, serum Uric acid and CRP will be measured on day 0 .Troponin t will be measured by Dry Chemistry (turbidimetric method) and will be repeated after twelve hours if initially found negative, Uric acid by Uricase method and CRP by turbidimetric method. Patients will be followed up over a period of seven days. Death ,Heart failure(Killip class I to IV), recurrent ACS and LV ejection fraction will be taken as end points of the study . All the values will be statistically compared to determine a single bio marker predicting the prognosis. Inclusion Criteria (1)Age greater than or equal to 18 years. (2)Patients with first episode of Acute Coronary Syndrome. Exclusion Criteria (1)Patients with chronic kidney disease. (2) Gout, haematological malignancy ,hypothyroidism, patients on drugs raising uric acid level. (3)Patients in sepsis. (4) Patients suffering from connective tissue disorders. Data Analysis: Data will be analyzed by frequency , percentage , mean, standard deviation, ANOVA and Chi-Square. 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? YES The following investigations will be done Routine blood investigations- Haemoglobin, total cell count and differential count. Urine microscopy, serum creatinine. ECG , 2 D ECHO , troponin -T, Serum Uric acid and CRP.
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